(28 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire and its accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended to facilitate the placement and exchange of other interventional devices, not to perform a therapeutic action itself.
No
The device is a guide wire system intended to facilitate the placement and exchange of interventional devices during procedures, not to diagnose a condition itself. While it is used in both diagnostic and therapeutic interventional procedures, its role is facilitative for other devices, not diagnostic inherently.
No
The device description clearly details physical components like a stainless steel core, PTFE coating, platinum-tungsten marker coil, and a torque device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures." This describes a device used within the body to aid in medical procedures, not a device used to test samples outside the body.
- Device Description: The description details a physical guide wire designed for navigation within the vascular system. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Wholey Guide Wire System is an interventional medical device used in vivo, not an in vitro diagnostic device used in vitro.
N/A
Intended Use / Indications for Use
The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Product codes
DQX
Device Description
The Wholey™ Guide Wire System is a 0.035" guide wire available in lengths of 145, 175, 260 and 300cm. The distal tip flex configurations are Standard, Floppy, and Intermediate. Tip shape is Straight or Modified J. The guidewire is composed of a stainless steel core, green PTFE (polytetrafluoroethylene) coated coil, white PTFE sleeve, platinum-tungsten marker coil, and optional extension system connector. The proximal end of the core is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100cm of the guidewire is covered with a green PTFE pre-coated coil. The PTFE coated coil and platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque.
A torque device is packaged with the guide wire as an accessory. The polycarbonate/brass torque device is designed to be secured to the proximal portion of a guide wire with a diameter, from 0.020" - 0.040" (0.50mm to 1.01mm) to facilitate steering of the guide wire within the vascular anatomy.
A Wholey Extension Wire is an available accessory consisting of a PTFE coated stainless steel guide wire attachment which is 0.035" (0.900 mm) in diameter and 155 cm in length. It is exclusively compatible with 0.035" (0.900 mm) Wholey guide wires which have been modified for the attachment of the Wholey Guide Wire Extension to facilitate device exchange. Refer to the Wholey Guide Wire Extension instructions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular anatomy, tortuous arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing and a GLP animal study were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. Test methods were developed using FDA Coronary and Cerebrovascular Guidewire guidance and ISO 11070:1998 in order to demonstrate equivalence of the Wholey Guide Wire System to the predicate device. A list of applicable non-clinical tests included performed at baseline and one year aging include:
Distal Pull Strength
Combined Load
Torque Response
Tip Flexibility
Coating Durability
Lubricity and Catheter Compatibility
Pouch Peel
Dye Penetration
Linear Stiffness
Dimensional
Visual Fracture - ISO
Flex - ISO
Corrosion
Strength of Union – Distal Tip
Shape Retention
Tip Load
Hypotube Flex
Jacket Adhesion
Body Stiffness (3-Point Bend)
Particulate
Radiopacity
Packaging Distribution
Thermal Conditioning
Lateral Stiffness
Biocompatibility testing per ISO 10993 series was performed on the Wholey Guide Wire System and test results met the specified acceptance criteria.
Cytotoxicity
Thrombogenicity
Kligman Maximization Test
Systemic Toxicity
Rabbit Pyrogen
Hemolysis
Complement Activation Assay
Lee and White Coagulation
Unactivated Thromboplastin Time Assay
USP Physicochemica Test
Inhibition and Enhancement
A GLP animal study was completed to evaluate safety and performance of the Wholey Guide Wire System compared to the currently marketed predicate device. The study showed the Wholey Guide Wire System is substantially equivalent to the predicate device for the evaluated safety and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
APR 1 9 2012
Image /page/0/Picture/1 description: The image shows the number K120863 at the top. Below the number is the COVIDIEN logo. The logo is a square with a white shape inside of it, followed by the word COVIDIEN in all caps.
510(k) Summary
Wholey™ Guide Wire System
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21
C.F.R § 807.92. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Covidien llc, formerly ev3, Inc. |
| Submitter | Covidien llc
3300 Campus Drive, Suite N550
Plymouth, MN 55441
Tel: 763-398-7000
Fax: 763-591-3248 |
| Contact Person | David Robertson
Regulatory Affairs Specialist |
| Date Prepared | February 3, 2012 |
| Device Trade Name | Wholey™ Guide Wire System |
| Device Common
Name | Catheter Guide Wire |
| Classification Name | Wire, Guide, Catheter (21 CFR 870.1330), Product Code DQX |
| Classification Panel | Cardiovascular |
| Predicate Devices | Advanced Cardiovascular Systems Inc., Wholey™ Hi-Torque®
Guide Wire (K861765) |
| Device Description | The Wholey™ Guide Wire System is a 0.035" guide wire
available in lengths of 145, 175, 260 and 300cm. The distal tip
flex configurations are Standard, Floppy, and Intermediate. Tip
shape is Straight or Modified J. The guidewire is composed of a
stainless steel core, green PTFE (polytetrafluoroethylene) coated
coil, white PTFE sleeve, platinum-tungsten marker coil, and
optional extension system connector. The proximal end of the
core is covered by a white PTFE sleeve that terminates at 100cm
from the distal tip. The distal 100cm of the guidewire is covered
with a green PTFE pre-coated coil. The PTFE coated coil and |
| | platinum-tungsten coil are welded to the core on the very distal
tip. The distal tip is shapeable and radiopaque. |
| | A torque device is packaged with the guide wire as an accessory.
The polycarbonate/brass torque device is designed to be secured
to the proximal portion of a guide wire with a diameter, from
0.020" - 0.040" (0.50mm to 1.01mm) to facilitate steering of the
guide wire within the vascular anatomy. |
| | A Wholey Extension Wire is an available accessory consisting
of a PTFE coated stainless steel guide wire attachment which is
0.035" (0.900 mm) in diameter and 155 cm in length. It is
exclusively compatible with 0.035" (0.900 mm) Wholey guide
wires which have been modified for the attachment of the
Wholey Guide Wire Extension to facilitate device exchange.
Refer to the Wholey Guide Wire Extension instructions for use. |
| Indication for Use | The Wholey Guide Wire System is intended to facilitate the
placement and exchange of interventional devices during
diagnostic or therapeutic interventional procedures. The guide
wire can be torqued to facilitate navigation through tortuous
arteries and/or avoid unwanted side-branches. |
| Performance data | Bench testing and a GLP animal study were performed to
support a determination of substantial equivalence. Results from
this testing provide assurance that the proposed device has been
designed and tested to assure conformance to the requirements
for its intended use. Test methods were developed using FDA
Coronary and Cerebrovascular Guidewire guidance and ISO
11070:1998 in order to demonstrate equivalence of the Wholey
Guide Wire System to the predicate device. A list of applicable
non-clinical tests included performed at baseline and one year
aging include: |
| | Distal Pull Strength Combined Load Torque Response Tip Flexibility Coating Durability Lubricity and Catheter Compatibility Pouch Peel Dye Penetration Linear Stiffness Dimensional Visual Fracture - ISO Flex - ISO Corrosion Strength of Union – Distal Tip Shape Retention Tip Load Hypotube Flex Jacket Adhesion Body Stiffness (3-Point Bend) Particulate |
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Radiopacity
and Packaging Distribution
Thermal Conditioning
Wholey™ Guide Wire System 510(k) Summary
.
Lateral Stiffness
| | | acceptance criteria.
Cytotoxicity | Biocompatibility testing per ISO 10993 series was performed on
the Wholey Guide Wire System and test results met the specified
Thrombogenicity |
|------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | �
�
0 | Kligman
Maximization Test
Systemic Toxicity
Rabbit Pyrogen
Hemolysis
Complement
Activation Assay | Lee and White
Coagulation
Unactivated
Thromboplastin Time
Assay
USP Physicochemica
Test
Inhibition and
Enhancement |
| | criteria. | A GLP animal study was completed to evaluate safety and
predicate device for the evaluated safety and performance | performance of the Wholey Guide Wire System compared to the
currently marketed predicate device. The study showed the
Wholey Guide Wire System is substantially equivalent to the |
| Summary of
Substantial
Equivalence | �
●
● | the predicate devices:
Similar basic design and fundamental scientific
technology
Similar operating principle
Similar core wire materials
Similar wire diameter
Similar wire lengths
Similar tip styles | The Wholey Guide Wire System has the following similarities to |
| | | | The characteristics that differ from the predicate device are the: |
| | ●
●
● | Distal core head
Radiopaque marker coil
PTFE coated distal 8cm
Lack of intermediate joint at 8cm
Lack of adhesive between coil and sleeve | |
| Carolian | | 3033 Camble Drive | ﺮ ﻣﺮﻳﻜ
753-398-7000 (T) |
| | | タンさんなのです。 Nici | 783-398-7200 (E) |
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- White PTFE sleeve .
- . Braze extension adapter
Based on the similar indications for use, technological Conclusion characteristics, and results from in-vitro and in-vivo testing, Covidien IIc considers the Wholey™ Guide Wire System substantially equivalent to the Wholey™ Hi-Torque® Guide Wire (K861765).
| CRITICAL: | 3033 Carters Drive | 763-393-7000 [T] |
|---|---|---|
| Plymouth, MN | 763-393-7200 [F] | |
| 55441 |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2012
Covidien LLC c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K120863
Trade/Device Name: Wholey Guide Wire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (Two) Product Code: DQX Dated: March 21, 2012 Received: March 22, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A. Hilleben
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health ·
Enclosure
6
Page 1 of 1
Indications for Use Statement .
510(k) Number (if known): K120863
Device Name: Wholey Guide Wire System
Indications for Use:
The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. A. Hilliam
(Division Sign-Off) (Division Sign-oll)
Division of Cardiovascular Devices
510(k) Number K120863